Suture system and assembly including a tubular leader having a clasp

ABSTRACT

A suture system includes a tool and a suture assembly. The tool includes a head having a proximal portion housing a needle and a distal end spaced apart from the proximal portion by a throat. The needle is movable through a needle exit port formed in the proximal portion of the head to a cavity formed in the distal end of the head. The suture assembly includes a length of suture connected to a tubular leader. The tubular leader includes an annular wall extending between an interior surface and an exterior surface, and a clasp having a first portion disposed between the interior surface and the exterior surface of the annular wall and a second portion extending out of the annular wall and adapted to secure the suture against the annular wall.

BACKGROUND

Intracorporeal suturing of tissue during surgery presents challenges tothe surgeon in that the surgeon is called upon to manipulate suturinginstruments within the confines of a relatively small incision formed inthe patient's body. In some cases, the surgeon digitally palpates adesired location for placement of the suture and is unable to see thesuture site.

Improved suturing instruments and improved methods of delivering sutureswould be welcomed by the surgical staff.

SUMMARY

One aspect provides a suture system configured to place suture intissue. The suture system includes a tool and a suture assembly. Thetool includes a head having a proximal portion housing a needle and adistal end spaced apart from the proximal portion by a throat. Theneedle is movable through a needle exit port formed in the proximalportion of the head to a cavity formed in the distal end of the head.The suture assembly includes a length of suture connected to a tubularleader. The tubular leader includes an annular wall extending between aninterior surface and an exterior surface, and a clasp having a firstportion disposed between the interior surface and the exterior surfaceof the annular wall and a second portion extending out of the annularwall and adapted to secure the suture against the annular wall. Thetubular leader is sized to be placed in the cavity formed in the distalend of the head and the needle is configured to engage with the interiorsurface of the tubular leader to extract the tubular leader from thecavity and deliver it to the needle exit port.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a side plan view of a suturing instrument according to oneembodiment.

FIG. 2 is a cross-sectional view of one embodiment of a handle of thesuturing instrument illustrated in FIG. 1.

FIG. 3 is a side view of one embodiment of a shaft of the suturinginstrument illustrated in FIG. 1.

FIG. 4 is a cross-sectional view of one embodiment of a push roddisposed within the shaft illustrated in FIG. 3.

FIG. 5 is a cross-sectional view of a head of the suturing instrumentillustrated in FIG. 1 including a movable needle according to oneembodiment.

FIG. 6 is a cross-sectional view of a suture assembly including sutureattached to a capsule that is configured to couple with a needle of thesuturing instrument illustrated in FIG. 1 according to one embodiment.

FIG. 7A is a schematic cross-sectional view of the head of the suturinginstrument illustrated in FIG. 5 with the needle retracted within thehead according to one embodiment.

FIG. 7B is a cross-sectional view of the head of the suturing instrumentillustrated in FIG. 5 with the needle partially extending from an exitport of the head according to one embodiment.

FIG. 7C is a cross-sectional view of the head of the suturing instrumentillustrated in FIG. 5 with the needle thrown into the distal end of thehead and engaged with the suture assembly illustrated in FIG. 6according to one embodiment.

FIGS. 7D-7F are schematic cross-sectional views of the needle of thesuturing instrument illustrated in FIG. 1 engaged with the sutureassembly and retracting a capsule of the suture assembly back into aproximal end portion of the head according to one embodiment.

FIG. 8 is a flow diagram of a method of suturing tissue according to oneembodiment.

FIG. 9A is a cross-sectional view of another embodiment of a handleconfigured for use with the suturing instrument illustrated in FIG. 1.

FIG. 9B is a cross-sectional view of another embodiment of a handleconfigured for use with the suturing instrument illustrated in FIG. 1.

FIG. 10 is a cross-sectional view of another embodiment of a handleconfigured for use with the suturing instrument illustrated in FIG. 1.

FIG. 11 is a cross-sectional view of another embodiment of a handleconfigured for use with the suturing instrument illustrated in FIG. 1.

FIG. 12 is a cross-sectional view of another embodiment of a handleconfigured for use with the suturing instrument illustrated in FIG. 1.

FIG. 13 is a cross-sectional view of another embodiment of a handleconfigured for use with the suturing instrument illustrated in FIG. 1.

FIG. 14 is a perspective view of another embodiment of a shaftconfigured for use with the suturing instrument illustrated in FIG. 1.

FIG. 15 is a cross-sectional view of another embodiment of a shaftconfigured for use with the suturing instrument illustrated in FIG. 1.

FIG. 16 is a cross-sectional view of another embodiment of a headconfigured for use with the suturing instrument illustrated in FIG. 1.

FIG. 17 is a cross-sectional view of another embodiment of a headconfigured for use with the suturing instrument illustrated in FIG. 1.

FIG. 18 is a side schematic view of one embodiment of a suture systemincluding a tool and a suture assembly.

FIG. 19 is a perspective view of one embodiment of a tubular leader ofthe suture assembly illustrated in FIG. 18.

FIG. 20 is a cross-sectional view of the tubular leader illustrated inFIG. 19.

FIGS. 21A and 21B are distal end views of embodiments of the tubularleader illustrated in FIG. 19.

FIG. 22 is a cross-sectional view and FIG. 23 is a distal end view ofone embodiment of a tubular leader suitable for use with the sutureassembly illustrated in FIG. 18.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Tissue includes soft tissue, which includes dermal tissue, sub-dermaltissue, ligaments, tendons, or membranes. As employed in thisspecification, the term “tissue” does not include bone.

In this specification, shunt means to move an object away from a firstaxis to another axis that is different from the first axis. For example,in one embodiment a suturing device includes a needle that is moved in afirst direction (e.g., along a longitudinal axis) and is subsequentlymoved in a second direction different from the first direction (i.e.,away from the longitudinal axis); thus the needle is shunted away from alongitudinal axis when deployed from the device.

In this specification, end means endmost and end portion means thatsegment that is adjacent to and extends from the end. For example, aproximal end is that end location of a handheld instrument that isnearest a user, and a proximal end portion is that segment (e.g., ahandle of the handheld instrument) that is adjacent to and extendsdistally away from the proximal end.

Embodiments provide a suturing tool having a needle housed in a proximalend portion of a head of the tool, where the needle is deployedlongitudinally out of the proximal end portion of the head through amass of tissue and subsequently grasps a suture assembly. The needleretracts after engaging the suture assembly and pulls the sutureassembly through the needle-hole (e.g., lesion) formed in the tissue. Inthis manner, the needle reaches through the tissue, grasps the sutureassembly, and retracts the suture assembly through the tissue tocomplete a “stitch” in the tissue.

In one embodiment, a suture system is provided that includes the sutureassembly and a capsule that is attached to a length of suture.Embodiments of the suturing assembly include a head having a distal endthat defines a cavity sized to retain the capsule. A needle is housedwithin a proximal end portion of the head and is movable from a needleexit port into the cavity formed in the distal end of the head. Theneedle is configured to engage the capsule of the suture assembly.

Embodiments provide a suturing assembly having a linear head that isconfigured to throw a needle longitudinally out of a needle exit port,across a throat space, and into a cavity formed in a distal end of thelinear head.

Embodiments provide a suturing assembly having a head with a radiallyoffset distal end, where the head is configured to throw a needlelongitudinally in a first direction through a needle exit port, shuntthe needle away from the longitudinal axis in a second directiondifferent from the first direction, and into the cavity formed in theradially offset distal end.

Embodiments provide a suturing assembly configured to throw a needleinto frictional engagement with a capsule towing a length of suture. Thesuturing assembly places a stitch in the tissue each time the capsule isretrieved, and the surgeon, upon seeing the retrieved capsule, isprovided with positive visual feedback of the successful application ofthe suture.

FIG. 1 is a side plan view of a suturing assembly 50 configured to placesuture in tissue according to one embodiment. Suturing assembly 50includes a handle 52, a shaft 54 coupled to handle 52, and a head 56coupled to shaft 54. Handle 52 thus defines a proximal end of suturingassembly 50 and is nearest a user of suturing assembly 50.

In one embodiment, handle 52 includes an actuator 58 communicating witha rod 60 that is disposed within shaft 54. When actuator 58 isactivated, rod 60 moves through shaft 54 to extend a needle 62 storedwithin a proximal end portion of head 56 axially outward through tissueand toward a distal end 64 of head 56. Thus, needle 62 moves away fromthe user (who is holding handle 52 at the proximal end of suturingassembly 50) toward distal end 64 of suturing assembly 50.

In one embodiment, a capsule (not shown) is retained within distal end64, and needle 62 is shaped to frictionally engage and mate with thecapsule, remove the capsule from distal end 64, and retract the capsuleinto the proximal end portion of head 56. In this manner, the suturetowed behind the capsule is “thrown” through the tissue. Embodimentsdescribed below include a guide pin located within head 56 that isconfigured to disengage the capsule from needle 62.

Suturing assembly 50 is suited for the intracorporeal suturing of tissueduring surgery, and in one embodiment is provided as a steriledisposable surgical instrument that is discarded after the surgicalprocedure. To this end, the components of assembly 50 are selected to becompatible with gas, steam, or radiation sterilization.

FIG. 2 is a cross-sectional view of one embodiment of a handle 52. Inone embodiment, handle 52 is aligned with a major longitudinal axis Aand includes a body 70 extending between a distal end 72 and a proximalend 74, a thumb brace 76 extending laterally from body 70, a trigger 78spaced apart from thumb brace 76, and a knob 80 coupled to proximal end74.

In one embodiment, body 70 is fabricated from plastic, for example viainjection molding. Suitable plastic materials for the fabrication ofbody 70, brace 76, and knob 80 include, as examples, polycarbonate,polyethylene, acrylonitrile butadiene styrene, acrylic, or nylon. In oneembodiment, brace 76 is integrally molded with a clamshell-style of body70 and these two components are joined together to retain trigger 78 andknob 80. Trigger 78 is formed to have sufficient strength to resistbending when activated by the human hand. Suitable materials for formingtrigger 78 include metal such as aluminum or plastics such aspolyetherimide or poly-ether-ether-ketone.

Shaft 54 is coupled to distal end 72 of body 70, and rod 60 is disposedwithin shaft 54 and coupled to trigger 78. In one embodiment, actuator58 includes trigger 78 attached to rod 60 and a spring 82 disposedwithin a spring pusher 84 and biased against and an internal rib 86.Trigger 78 is movable toward thumb brace 76 to move rod 60 in a distaldirection longitudinally within shaft 54, which compresses spring 82.When trigger 78 is released, spring 82 extends to push spring pusher 84proximally, which retracts or returns rod 60 toward proximal end 74.Trigger is spaced apart from thumb brace 76 by a distance ofapproximately 4-12 cm to enable the fingers of the user to comfortablyactivate trigger 78. Trigger 78 is disposed at an angle B relative tothe longitudinal axis A of body 70, and in an exemplary embodiment theangle B is between 70-110 degrees such that trigger 78 is approximatelyorthogonal to longitudinal axis A.

Actuator 58 is configured to move rod 60 forward in a distal directionand rearward in a proximal direction within shaft 54. In one embodiment,it is desirable to move rod 60 rearward an additional distance todisengage the suture assembly described below from needle 62 (FIG. 1).To facilitate this, rod 60 includes an insert (not shown) thatcommunicates through spring pusher 84 and is captured in window 88. Whenknob 80 is turned, spring pusher 84 turns and the insert attached to rod60 is retracted back in a proximal direction due to the angle of window88, which retracts rod 60 an additional distance into body 70. Forexample, in one embodiment knob 80 is configured such that a 180 degreeclockwise of knob 80 relative to end 74 draws rod 60 an additionaldistance of about 2 mm into body 70. Although knob 80 is configured toretract rod 60 further into body 70 via a turning motion, othermechanisms such as levers or draw bars for retracting rod 60incrementally rearward are also acceptable.

FIG. 3 is a side view of shaft 54. One suitable embodiment of shaft 54includes a substantially rigid aluminum annular tube extending between aproximal end that is attachable to handle 52 (FIG. 1) and a distal endthat is attachable to head 56. Other substantially rigid materials, suchas stainless steel, are also suitable selections for fabricating shaft54. Another embodiment of shaft 54 includes a distal end portionassociated with distal end 92 that is flexible and configured to bendlaterally relative to first section 96 to enable the surgeon toselectively direct head 56 to a desired location.

For example, one embodiment of shaft 54 includes a proximal end 90 thatis attachable to handle 52 (FIG. 1), a distal end 92 that is attachableto head 56 (FIG. 1), and a crimp 94 or a weld 94 connects a firstsection 96 to a second section 98. In one embodiment, shaft 54 is formedas a thin-walled tube with first section 96 formed of a first materialand a second section 98 is formed of a different second material. In anexemplary embodiment, first section 96 is formed of 6,000 seriesaluminum and a second section 98 is formed of 3000 series aluminum, withthese two metal sections 96, 98 joined together by crimp/weld 94. The6000 series aluminum is selected to have a shear modulus of a sufficientvalue to preclude the user from bending first section 96 as instrument50 is manipulated. For example, in one embodiment the shear modulus offirst section 96 is approximately 30 GN/m². The 3000 series aluminum isselected to have a shear modulus of a sufficient value to enable a userto bend the second section 98 with their hands, which enables the userto shape and guide second section 98 (which is attached to head 56) incontrolling and guiding the placement of sutures with head 56. Forexample, in one embodiment the shear modulus of second section 98 isapproximately 10 GN/m². In another example, in one embodiment the yieldstrength of first section 96 is approximately 30 GN/m². The 3000 seriesaluminum is selected to have a yield strength of a sufficient value toenable a user to bend the second section 98 with their hands, whichenables the user to shape and guide second section 98 (which is attachedto head 56) in controlling and guiding the placement of sutures withhead 56. For example, in one embodiment the yield strength of secondsection 98 is approximately 10 GN/m².

One example of suitable lengths for sections 96, 98 is for first section96 to have a length between 4-24 cm and second section 98 to have alength between 1-10 cm. Other lengths for sections 96, 98 are alsoacceptable. In one embodiment, crimp/weld 94 is provided as a metalperipheral crimp securing first section 96 to second section 98.

FIG. 4 is a cross-sectional view of rod 60 disposed within shaft 54. Rod60 generally includes a proximal end 100 that couples with push rod 84(FIG. 2) and a distal end 102 that communicates with needle 62. In oneembodiment, proximal end 100 of rod 60 is rigid and the remainingportion of rod 60 is formed to include a coiled spring, where multiplecoils 104 abut such that rod 60 has sufficient column strength (e.g.,along its major axis) to enable rod 60 to activate needle 62 and isprovided with flexibility to bend laterally. In one embodiment, anentire length of rod 60 is formed of a coiled stainless steel spring andis constrained within shaft 54 (FIG. 3) to provide rod 60 with a columnstrength configured to resist buckling under axial loads, and the coils104 are configured to enable head 56 (FIG. 1) to flex and move laterallyunder the application of a radial load. In this manner, the user ofinstrument 50 (FIG. 1) can bear down on shaft 54 and rod 60 to apply aforward-applied force, while also having the flexibility and control ofshaping where head 56 is oriented relative to handle 52.

In one embodiment, rod 60 is formed of a coiled stainless steel springand includes a polyethylene jacket, as one example, disposed around thecoiled spring.

In one embodiment, only a leading section 106 of rod 60 is formed ofcoiled springs 104, where leading section 106 corresponds to theflexible second section 98 of shaft 54, such that rod 60 is providedwith substantially the same lateral flexibility as shaft 54.

In one embodiment, rod 60 is formed of aluminum and configured to havesimilar flexibility as shaft 54.

FIG. 5 is a cross-sectional view of head 56. In one embodiment, head 56is formed of two mating clamshell components, and the view of FIG. 5 istaken with one half of the clamshell structure removed so that theinternal features of head 56 are visible. Head 56 is molded fromplastic, for example from a polyether imide plastic sold under thetrademark Ultem, or from glass-filled polyether imide plastics also soldunder the trademark Ultem.

In one embodiment, head 56 includes a proximal end 110 opposite distalend 64, a proximal end portion 112 extending from proximal end 110, anda neck 114 that extends between proximal end portion 112 and distal end64. Head 56 is attachable to shaft 54, and in one embodiment includes anopening 120 sized to receive shaft 54 such that rod 60 extends intoproximal end portion 112 and couples with a link 122 that is attached toneedle 62. In one embodiment, distal end 64 is not aligned with, but israther offset radially from longitudinal axis A, to more comfortablyposition shaft 54 for manipulation by the surgeon as head 56 is engagedwith tissue.

In one embodiment, a clevis pin 121 connects a proximal end of link 122to rod 60 and a distal end of link 122 is coupled to needle 62. Movementof rod 60 moves link 122, which moves needle 62 into and out of a needleexit port 123 formed in proximal end portion 112. In one embodiment, atrace 124 that is formed on an interior surface 125 of proximal endportion 112 of head 56, and link 122 is configured to translate androtate within trace 124 to translate needle 62 along axis A and pitchneedle up/down relative to axis A. For example, in one embodiment link122 includes a first pin 126 that couples with clevis 121 and a secondpin 128 that couples with needle 62. Axial movement of rod 60 translatesto axial movement of link 122 and needle 62, and link 122 rotates aboutpins 126, 128 to shunt a path of needle 62 off of axis A.

Link 122 is thus configured to translate within trace 124 to move needle62 in/out relative to needle exit port 123, and rotate relative to pins126, 128 to direct movement of needle 62 up/down relative tolongitudinal axis A. In one embodiment proximal end portion 112 includesa guide pin 130 that defines a bore sized to receive needle 62. Needle62 is configured to slide through the bore formed in guide pin 130, andguide pin 130 is rotatable to allow needle 62 to pitch relative tolongitudinal axis A as needle 62 moves axially, for example as needle 62moves into engagement with distal end 64.

Neck 114 extends between proximal end portion 112 and distal end 64 anddefines a throat 132. Needle 62 is movable from proximal end portion112, out of needle exit port 123, across throat 132, and into a cavity134 formed in distal end 64. In one embodiment, distal end 64 and cavity134 are both radially spaced away from longitudinal axis A, and guidepin 130 rotates to enable needle 62 to move out of the needle exit port123, pitch upwards, and into cavity 134. In one embodiment, a topsurface of neck 114 defines an open, exposed groove configured toreceive and guide suture that extends from the capsule 152 (FIG. 6)captured in cavity 134 back to handle 52 (FIG. 1).

As described below, cavity 134 is configured to retain a capsuleattached to suture (see FIG. 7), and needle 62 is configured topenetrate tissue and enter cavity 134, engage the capsule, and pull thecapsule through the tissue and into needle exit port 123 to “throw” thesuture across throat 132. As described below, embodiments of head 56include mechanisms configured to linearly direct needle 62 out of needleexit port 123 across throat 132 and into cavity 134 for engagement withthe capsule. Other embodiments of head 56 include mechanisms configuredto shunt needle 62 (e.g., pitch needle 62 upward relative to axis A awayfrom needle exit port 123 and into cavity 134 for engagement with thecapsule).

FIG. 6 is a side view of needle 62 aligned for engagement with a sutureassembly 150 according to one embodiment. Needle 62 is preferablymachined from metal such as stainless steel or a shape memory alloy suchas NITINOL (Nickel Titanium Naval Ordinance Laboratory), as examples.Suture assembly 150 includes a capsule 152 and suture 154 extending fromcapsule 152. In one embodiment, capsule 152 is molded from plastic tointegrally capture suture 154. Suitable plastic materials forfabricating capsule 152 include polypropylene, polysulfone, urethane, orpolyetherimide as examples. Suture 154 includes monofilament suture,braided suture, coated suture materials or the like, as examples.

Capsule 152 is sized to be deposited and retained in cavity 134 (FIG. 5)and defines a recess 156 configured to receive a leading end 158 ofneedle 62. In one embodiment, needle 62 is shaped to promote secureengagement with capsule 152 and leading end 158 is formed to have aconical point with a shoulder 162 that is sized to be pressed intoengagement with a flange 164 of recess 156. For example, flange 164 thatis shaped and sized to frictionally engage (e.g., snap-fit) in a“locked” manner with a shoulder 162 of needle 62 as needle 62 is driveninto recess 156. Capsule 152 is configured to be detached from needle 62by guide pin 130 (FIG. 5) after needle 62 pulls capsule 152 rearward ina proximal direction into head 56.

The conical point of needle 62 is configured to form a channel whenadvanced through tissue, and capsule 152 is sized to be pulled throughthe channel in the tissue made by needle 62. In one embodiment, leadingend 160 of capsule 152 is chamfered and needle 62 is configured to drawthe chamfered (or truncated) end 160 of capsule 152 first through thetissue. In one embodiment, leading end 160 of capsule 152 is a blunt endsimilar to that illustrated for the trailing end of the capsule 152, andneedle 62 is configured to draw the blunt end 160 of capsule 152 bluntend-first through the tissue.

For example, in one embodiment needle 62 has a first diameter D1 andcapsule 152 has a diameter D2, were diameter D1 is equal to or greaterthan diameter D2. In this manner, capsule 152 is sized to follow needle62 and be retracted through the channel formed in the tissue by needle62.

Leading end 158 of needle 62 is sized to frictionally engage with recess156 formed in capsule 152. For example, in one embodiment leading end158 has a diameter D3 that is slightly greater than a diameter D4 formedin an opening of recess 156. In this manner, when leading end 158 ofneedle 62 is inserted into recess 156, leading end 158 is forced intoand seats within and captures capsule 152.

FIGS. 7A-7F are schematic cross-sectional views illustrating a suturingsystem 166 including suturing device 50 and suture assembly 150 employedto throw needle 62 from a proximal location to a distal location of head56, engage needle 62 with a capsule 152/suture 154 of assembly 150, andretract capsule 152/suture 154 through tissue.

FIG. 7A is a schematic cross-sectional view of system 166 with needle 62fully retracted within needle exit port 123 of proximal end portion 112of head 56. Capsule 152 is seated in cavity 134 with suture 154 trailingdistal of head 56. In one embodiment, it is recommended that the surgeondirect a trailing end of suture 154 over distal end 64 of head 56 andback toward a proximal end of shaft 54 for ease of managing sutureassembly 150 during the procedure. For example, one embodiment of distalend 64 includes a slot configured to enable the suture 154 to passthrough distal end 64 to facilitate loading capsule 152 into cavity 134.In one embodiment, rod 60 and needle 62 are aligned on axis A whenneedle 62 is retracted into proximal end portion 112 as illustrated, andcapsule 152 is aligned on an axis C that is not aligned with axis A.

FIG. 7B is a schematic cross-sectional view of system 166 with needle 62partially extending from needle exit port 123 after activation ofactuator 58 (FIG. 1). Moving rod 60 axially in a distal direction movesneedle 62 out of needle exit port 123 in a first direction along axis A.In one embodiment, distal end 64 is radially spaced apart fromlongitudinal axis A by a distance H, such that the first direction isoriented along axis A, which results in the pathway of needle 62 beingoffset from cavity 134 by a distance H. A portion of needle 62 extendsfrom needle exit port 123 partway across throat 132, and guide pin 130is configured to rotate counter-clockwise to allow the movement of link122 within trace 124 to shunt the leading end 158 of needle 62 away fromthe first direction oriented along axis A to a second direction alignedwith an axis C that extends through cavity 134.

FIG. 7C is a schematic cross-sectional view of system 166 includingneedle 62 shunted away from longitudinal axis A by link 122 and pin 130,moved in a second direction along axis C by rod 60, and engaged withcapsule 152. Guide pin 130 has rotated counterclockwise to allow themovement of link 122 within trace 124 to shunt the direction of needle62 out of alignment with axis A and into alignment with axis C.Additional forward movement of rod 60 will further direct needle 62across throat 132 and into engagement with capsule 152. As describedbelow, needle 62 is reversible along the paths coincident with axis Cand axis A to retract needle 62 and capsule 152 into needle exit port123.

FIGS. 7D-7F are schematic cross-sectional views of needle 62 engagedwith capsule 152 and operable to retract and park capsule 152 back inthe proximal end portion 112 of head 56.

FIG. 7D is a schematic view of needle 62 engaged with capsule 152 andretracted along axis C a short distance such that capsule 152 isextracted out of cavity 134 and into throat 132. Additional rearwardretraction of rod 60 will cause guide pin 130 to rotate clockwise toallow the movement of link 122 within trace 124 to shunt needle 62 offof axis C and into alignment with axis A. Suture 154 trails behindcapsule 152 and out of a backside of cavity 134.

FIG. 7E is a schematic view of needle 62 partially retracted intoproximal end portion 112 of head 56. Link 122 has moved to a midpoint oftrace 124 such that needle 62 and capsule 152 have shunted down intoalignment with axis A. Retraction of rod 60 axially into shaft 54 drawsneedle 62 and capsule 152 into needle exit port 123.

FIG. 7F is a schematic view of needle 62 retracted into head 56 withcapsule 152 parked in needle exit port 123. In one embodiment, needleexit port 123 is sized to receive capsule 152 such that port 123 forms acapsule garage 123 into which capsule 152 is parked after extractionfrom cavity 134. Rod 60 has drawn link 122 into full rearward engagementwith trace 124 such that needle 62 is aligned with axis A and retractedinto head 56. Capsule 152 is parked inside needle exit port 123 andsuture 154 extends across throat 132, which provides the surgeon withguidance and control of the suture line.

In one embodiment, and as described above with reference to FIG. 2, knob80 is configured to be turned to incrementally retract rod 60 anadditional distance into handle 52, which separates needle 62 fromcapsule 152 that is parked in needle exit port 123. For example, theadditional retraction of needle 62 by the rearward motion of rod 60causes capsule 152 to be pressed against guide pin 130, which shearscapsule 152 off of needle 62. Needle 62 is thus disengaged from capsule152, which leaves capsule 152 parked in needle exit port 123. Theremoval of instrument 50 from the surgical site gives the surgeon accessto head 56 for the extraction of capsule 152 from needle exit port 123.The surgeon thereafter ties and terminates suture 154 as desired.

Embodiments of the suturing device described herein provide a method ofsuturing tissue useful in many surgical procedures, including thetreatment of pelvic organ prolapse. For example, embodiments provide asuturing device suited for the surgical treatment of pelvic organprolapse that is operable to suture a scaffold or other support to aligament or other tissue located relative to the pelvic floor. With somesurgical procedures it is desirable to apply sutures to the sacrospinousligament and/or in the arcus tendineus ligament to attach a syntheticscaffold thereto that is configured to support the pelvic floor andreduce or eliminate the undesirable effects of pelvic organ prolapse.

FIG. 8 is a flow diagram 170 of a method of suturing tissue. The methodincludes engaging tissue with a suturing head at 172. For example, acatheter is placed in the patient's urethra U, along with otherrecommended, desirable, and preliminary steps in preparation forsurgery. The patient is typically placed on an operating table in alithotomy position with buttocks extending just beyond an edge of thetable. With the patient under anesthesia, a vaginal incision (female) ora perineal incision (male) is made by the surgeon. Thereafter, thesurgeon would typically palpate the patient to identify a desiredlandmark, such as the sacrospinous ligament or arcus tendineus ligamentor other tissue landmark. The surgeon identifies the landmark, forexample with a finger, and subsequently introduces sterile instrument 50and engages throat 132 (FIG. 5) with the identified landmark.

At 174, the method includes driving a needle from a proximal portion ofthe suturing head through the tissue. Referencing FIG. 1 as an example,the surgeon activates actuator 58 to drive needle 62 out of proximal endportion 112 of head 56, through tissue, and into the identifiedligament.

At 176, the method includes engaging the capsule retained in the distalend of the suturing head with a needle, the capsule including a lengthof suture attached thereto. For example, the physician drives needle 62through the desired tissue location with actuator 58 until needle 62engages with capsule 152. Needle 62 forms a lesion in the tissue, andretracting needle 62 pulls capsule 152 through the lesion with suture154 following behind. The head 56 is disengaged from the landmark andsuturing device is removed from the patient to enable the physician toaccess and tie the suture.

The above-described methodology may be repeated at another site byinserting a new, second capsule and suture assembly into cavity 134 ofhead 56 and delivering the new suture assembly 150 to another tissuelocation of the patient. Upon completion of the procedure, suturingassembly 50 (FIG. 1) is properly disposed of in an approved waste streamof the surgical facility.

Needle 62 is deployed from head 56, and head 56 is compatible withmultiple different handle and/or shaft configurations, several of whichare described below.

FIG. 9A is a schematic cross-sectional view of handle 52 including avisual indicator 180. Handle 52 is similar to the handle illustrated inFIG. 2 and includes trigger 78 that is configured to move rod 60 axiallyforward and backward within shaft 54. In one embodiment, visualindicator 180 is formed as a see-through window 186 that enables a userto look through body 70 of handle 52 to discern a positional state ofpush rod 60.

In one embodiment, visual indicator 180 is configured to indicate afirst state in which needle 62 is responsive to actuator 58 and ready tobe thrown to engage with capsule 152 (FIG. 7A), and a second stateidentifying when knob 80 has been turned to disengage capsule 152 fromneedle 62 (FIG. 7F) and needle 62 is not ready to be thrown to engagewith another capsule 152.

For example, as described above, knob 80 is employed (e.g., turned) tofurther retract rod 60 into handle 52 and disengage capsule 152 fromneedle 62. When knob 80 has been turned and capsule 152 has beendisengaged from needle 62, rod 60 is “captured” by knob 80 and preventedfrom moving forward when trigger 78 is activated. Returning knob 80 toits initial position enables trigger 78 to fire (or throw) needle 62into engagement with cavity 134 and capsule 152 within cavity 134.

In one embodiment, a proximal end 181 of rod 60 includes a deploymentindicator 182 and a separate retracted indicator 184. Indicator 182 isconfigured to indicate that rod 60 is ready to be moved axially forwardwithin shaft 54 to push needle 62 out of needle exit port 123. Forexample, when the deployment indicator 182 is visible within window 186the user is informed that rod 60 is ready to deploy needle 62 andcapture a capsule 152 (the action of which is termed “throwing asuture”).

Retracting rod 60, for example by the spring-action described above,returns rod 60 to the retracted position indicated in FIG. 9A. When rod60 is drawn incrementally further back into handle 52 by turning knob80, for example to disengage capsule 152 from needle 62 (FIG. 7F),retracted indicator 184 becomes visible within window 186. The presenceof retracted indicator 184 within window 186 indicates that needle 62has been disengaged from capsule 152 and that knob 80 has not beenreturned to its initial position (and thus, rod 60 is not ready to fireneedle 62).

In one embodiment, deployment indicator 182 is provided as a first colorand retracted indicator 184 is provided as a second color different fromthe first color. For example, in one embodiment deployment indicator 182is green to indicate that needle 62 is ready to be thrown to engage withcapsule 152 and retracted indicator 184 is red to indicate that knob 80has been turned and needle 62 is not in position or ready to be firedtoward capsule 152. In another exemplary embodiment, deploymentindicator 182 is provided as an arrow to indicate that needle 62 isready to be thrown to engage with capsule 152 and retracted indicator184 is provided as an X to indicate that knob 80 has been turned andneedle 62 is not in position or ready to be fired toward capsule 152.

FIG. 9B is a cross-sectional view of another embodiment of an indicator183 for handle 52. In one embodiment, indicator 183 includes a first 183a indicia located on knob 80 and a second 183 b indicia located on body70 of handle 52. With additional reference to FIGS. 7A-7F, first 183 aindicia is aligned with second 183 b indicia when rod 60 is in positionto fire needle 62 to engage capsule 152, or when knob 80 has beenreturned to its initial position to ready rod 60 to fire needle 62 toengage capsule 152. For example, first 183 a indicia is a semi-circle ora mirror image of second 183 b indicia. When first 183 a indicia isaligned with second 183 b indicia and rod 60 is ready to fire needle 62,the images align as illustrated.

When knob 80 has been turned to retract rod 60 and disengage capsule 152from needle 62, first 183 a indicia is not aligned with second 183 bindicia, which indicates to the user that needle 62 is not ready to befired. For example, the half-oval of first 183 a indicia does notaligned with its mirror image of the half-oval of second 183 b indicia,as illustrated. However, knob 80 may be turned by the user to return itto its initial position in which rod 60 is in position to fire needle 62to engage capsule 152, in which case 183 a becomes aligned with 183 b.Indicator 183 includes color indicators, shapes on handle 52 and knob 80that mate to indicate alignment of knob 80 with handle 52 (asillustrated), or letters or numbers that indicate alignment and/ornon-alignment of knob 80 with handle 52.

FIG. 10 is a schematic cross-sectional view of another handle 200configured for use with suturing device 50 illustrated in FIG. 1. Handleis fabricated with materials similar to handle 52 described above.

In one embodiment, handle 200 includes a grip 202 coupled to shaft 54, arod 204 disposed within shaft 54, and a trigger 206 coupled to rod 204and configured to displace rod 204 axially within shaft 54. In oneembodiment, grip 202 includes a fixed collar 208 and rod 204 includes abase 210 that moves relative to collar 208 when trigger 206 is squeezed.In one embodiment, a biasing member 212 is disposed between collar 208and base 210. Squeezing trigger 206 draws base 210 toward fixed collar208, which moves rod 204 in a distal direction and stores energy withinbiasing member 212. Releasing trigger 206 causes biasing member 212 toforce base 210 back in a proximal direction to its neutral state. Inthis manner, handle 200 provides a bike brake-style handle that enablesrod 204 to move forward and back within shaft 54 when trigger 206 isactivated.

In one embodiment, handle 200 is provided in a familiar-to-use “bikebrake-style” that provides trigger 206 coupled to grip 202 at an anglebetween 0-10 degrees relative to the axis of shaft 54. In one example ofthis bike brake-style trigger 206 is substantially parallel to grip 202.

FIG. 11 is a schematic cross-sectional view of another handle 220configured for use with suturing device 50 illustrated in FIG. 1. In oneembodiment, handle 220 includes a proximal handle 222, a biasing member224 disposed within proximal handle 222, a collar 226, a first gearedrack 228 attached to collar 226 and communicating with biasing member224, a second geared rack 230 disposed within proximal handle 222, and afixed gear 232 disposed between first geared rack 228 and second gearedrack 230.

In one embodiment, proximal handle 222 is curved to accommodate palm ofa user, and collar 226 is configured to be engaged by fingers of theuser to pull collar 226 toward handle 222. First geared rack 228 isfixed relative to collar 226 and second geared rack 230 is attached topush rod 234. The geared racks 228, 230 move relative to each other byaction of gear 230 which is mated between racks 228, 230. When collar226 is squeezed toward proximal handle 222, gear 232 rotates clockwiseand geared rack 228 moves toward proximal handle 222, which compressesbiasing member 224. The rotation of gear 232 causes geared rack 230 totranslate in the distal direction (e.g., forward, along with handle222), which pushes rod 234 in a forward direction. Since rod 234 iscoupled to needle 62 (FIG. 5), needle 62 is thus moved forward (e.g.,“thrown”) when collar 226 is squeezed toward the arched proximal handle222 of handle 220. Biasing member 224 forces collar 226 away from handle222 when the squeezing force is relaxed, this “reloads” collar 226 tosubsequently throw additional sutures. The broad area of proximal handle222 comfortably distributes the applied force across the hand of theuser and collar 226 provides positive engagement with the fingers. Theseaspects combine to enable the user to direct high levels of force to thepush rod 234 in a comfort manner with little effort, which can beadvantageous for user's who have smaller hands.

FIG. 12 is a schematic cross-sectional view of another handle 240configured for use with the suturing device 50 illustrated in FIG. 1.Handle 240 is configured such that squeezing motion delivered laterallyrelative to shaft 54 results in axial movement of needle 62 from head 56(FIG. 5).

In one embodiment, handle 240 includes a grip 242 defining a distal endportion 244 opposite a proximal end 246, a squeezable member 248 pinnedto the distal end portion 244 of grip 242, and an actuator 250 that isconfigured to translate the lateral squeezing movement of squeezablemember 248 to axial movement of a rod 254 disposed within shaft 54. Inone exemplary embodiment, actuator 250 includes a first gear 260disposed within grip 242 and mated to a second gear 262, and squeezablemember 248 includes a geared rack 264 that is engaged with the secondgear 262. Rod 254 is coupled with first gear 260. When squeezable member248 is compressed laterally into grip 242, geared rack 264 moveslaterally and rotates gear 262 in a counter-clockwise direction, whichcauses gear 260 to rotate in a clockwise direction. The rotation of gear260 is translated to axial movement of rod 254 (and thus needle 62). Inanother exemplary embodiment, gear 260 is attached to a pair of cablesthat are spaced 180 degrees apart on round gear 260. The cables extendto a forward gear or pulley located within head 56 (FIG. 5). The cablesare balanced in a pulley arrangement such that rotation of gear 260clockwise tensions the upper cable, which rotates the forward gearclockwise to tension the lower cable. Thus, the cables replace thepush/pull function of rod 254.

In one embodiment, grip 242 is fabricated from plastic similar to thehandles for instrument 50 described above and is molded to include anergonomic tear-drop shape.

FIG. 13 is a schematic view of another handle 280 configured for usewith suturing device 50 illustrated in FIG. 1. Handle 280 is similar tohandle 52 (FIG. 1) and includes a trigger 286 that is configured toeject needle 62 from head 56 with a first squeeze of trigger 286 andretract needle 62 into head 56 with a subsequent squeeze of trigger 286.

In one embodiment, handle 280 includes a uni-directional gear 282coupled to a rack 284 that is provided with two degrees of freedom. Forexample, trigger 286 is pinned to rack 284, and a link 288 is pinnedbetween gear 282 and rod 60. Gear 282 is configured to rotate in onlyone direction (i.e., uni-directionally), which in this embodiment iscounter-clockwise. In an initial position, link 288 is positioned at the3 o'clock position of gear 282 (e.g., at the top), and squeezing trigger286 rotates gear 282 counter-clockwise to the 9 o'clock position, whichdisplaces link 288 distally forward to push rod 60 forward. Releasingtrigger 286 causes rack 284 to lift and skip over the teeth in gear 282(i.e., without gear 282 and rack 284 meshing), leaving link 288 at the 9o'clock position. Thus, rack 284 has at least two degrees of freedom:laterally left and right as oriented in FIG. 13 and up/down to disengagefrom gear 282. In this manner, rack 284 is retracted proximallybackwards relative to gear 282 without rotating gear 282. A secondsqueeze of trigger 286 again draws rack 284 forward and into engagementwith gear 282, rotating gear 282 counter-clockwise, which draws link 288rearward from the 9 o'clock position back and up to the 3 o'clockposition to retract push rod 60 within shaft 54. In this manner, handle280 provides a double action trigger 286 configured to throw a suture bymoving needle 62 forward with a first pull of trigger to 86 and retractneedle with a second pull of trigger 286.

The above described handles enable a surgeon to accurately and securelyplace a suture in tissue. In one embodiment, shaft 54 is provided as arigid shaft. However, the surgeon may desire to adjust the location ofhead 56 as a suture is thrown, or as subsequent sutures are placed.Instrument 50 provides for positional flexibility of head 56, forexample via flexible end section 98 of shaft 54 (FIG. 3). Additionalembodiments of flexible shafts that provide the surgeon with flexibilityin placing sutures are described below.

FIG. 14 is a perspective view of another embodiment of a shaft 300configured for use with suturing instrument 50 illustrated in FIG. 1.Shaft 300 includes a proximal end 302 that is attachable to a handle(such as handle 52 in FIG. 1) and a distal end 304 that couples with asuture throwing head (such as head 56 in FIG. 1). In one embodiment, adistal end portion 306 of shaft 300 includes a corrugated section thatprovides distal end portion 306 with lateral flexibility relative tosection 308. In one embodiment, shaft 300 is fabricated from stainlesssteel, and distal portion 306 is provided with an accordion-stylecorrugated structure that provides lateral flexibility for distal end304 of shaft 300. Suitable metals for shaft 300 include aluminum, steelincluding stainless steel, highly malleable metal such as copper, orother such suitable metals.

FIG. 15 is a perspective view of another embodiment of a shaft 320configured for use with suturing instrument 50 illustrated in FIG. 1.Shaft 320 includes a proximal end 322 that is attachable to a handle(such as handle 52 in FIG. 1) opposite a distal end 324 that coupleswith a suture throwing head (such as head 56 in FIG. 1), and a distalend portion 326 including one or more flexible coils 328. In oneembodiment, coils 328 are attached to an end portion 330 of shaft 320,for example by soldering or welding. In another embodiment, coils 328are disposed over a rigid end portion of shaft 320 and crimped in place.That is to say, in one embodiment coils 328 are integrally formed withshaft 320, and in a separate embodiment coils 328 are provided separatefrom shaft 320 and subsequently attached thereto. In any regard, distalend portion 326 of shaft 320 is provided with flexibility in the lateraldirection that enables the surgeon to move head 56 laterally relative tothe longitudinal axis of shaft 320. In one embodiment coils 328 areformed from copper and attached to end portion 330 of a stainless steelshaft 320.

FIG. 16 is a cross-sectional view of another head 350 configured for usewith suturing assembly 50 illustrated in FIG. 1. Head 350 is coupled toshaft 54 such that rod 60 extends through a portion of head 350 tocouple with needle 62.

In one embodiment, head 350 includes a proximal end 352 opposite adistal end 354, a proximal end portion 356 extending from proximal end352, and a neck 358 that extends between proximal end portion 356 anddistal end 354. In one embodiment, a throat 360 is formed betweenproximal end portion 356 and distal end 354, where proximal end portion356 defines a needle exit port 362 through which needle 62 moves.

In one embodiment, head 350 is provided as a linear head having a distalend 354 that defines a cavity 364 aligned with the major longitudinalaxis A of the suturing device. Cavity 364 is sized and configured toretain capsule 152 of suturing assembly 150 (FIG. 7). In one embodiment,needle 62 is provided as a substantially straight needle that is alignedon axis A of shaft 54 when stowed (e.g., stored or parked) withinproximal portion 356 of head 350. Needle 62 moves longitudinally out ofneedle exit port 362 along a substantially linear (straight) line andtraverses throat 360 by traveling along axis A. As described above,needle 62 is configured to engage capsule 152, remove capsule 152 fromcavity 364, and pull capsule 152 (and suture attached to capsule 152)proximally back across throat 360 to suture tissue engaged in throat360.

Head 56 (FIG. 5) provides an offset distal end 64 and head 350alternatively provides a linear arrangement between distal end portion356 and distal end 354. Rod 60 is rigidly coupled to needle 62, althoughit is acceptable to have a link coupled between rod 60 and needle 62, asdescribed above, where the link translates within a channel to moveneedle 62 along axis A and into engagement with capsule 152 (FIG. 7)that is retained within cavity 364. In one preferred embodiment, rod 60is rigidly coupled with needle 62 and configured to drive needle 62directly across throat 360 and into engagement with a capsule/sutureassembly placed in cavity 364. Other mechanisms for linearly deliveringneedle 62 from proximal end portion 356 of head 350 are also acceptable.

FIG. 17 is a cross-sectional view of another head 400 configured for usewith suturing assembly 50 illustrated in FIG. 1. Head 400 is configuredto be coupled to shaft 54 such that rod 60 extends through a portion ofhead 400 to couple with a linkage 402 that communicates with a curvedneedle 404.

Head 400 includes a proximal end 410 opposite a distal end 412, aproximal end portion 414 extending from proximal end 410, and a neck 416that extends between proximal end portion 414 and distal end 412. In oneembodiment, a throat 418 is formed between proximal end portion 414 anddistal end 412, where proximal end portion 414 defines a needle exitport 420 through which curved needle 404 exits proximal end portion 414.

In one embodiment, distal end 412 defines a cavity 422 that is sized andconfigured to retain capsule 152 of suturing assembly 150 (FIG. 7).Suture 154 (FIG. 7) of suture assembly 150 is directed over distal end412 and proximal end portion 414 for management by the surgeon near thehandle located proximal of the instrument. Curved needle 404 movesclockwise in this embodiment out of needle exit port 420 and includes aleading end 424 that is configured to engage with capsule 152, removecapsule 152 from cavity 422, and pull capsule 152 (and suture attachedto capsule 152) counter-clockwise back across throat 418 to suturetissue engaged in throat 418.

In one exemplary embodiment, linkage 402 includes a first link 430 and asecond link 440, where first link 430 includes a pin 432 coupled to rod60 and a second pin 434 coupled to second link 440. Second link 440 hasa pin 442 that defines a pivot point about which link 440 and needle 404rotates. In one embodiment, a trailing end 450 of curved needle 404 iscoupled to a juncture of first link 430 and second link 440 by pin 434.

Rod 60 is retractable, for example by actuator 58 illustrated in FIG. 1.Movement of rod 60 toward distal end 412 of head 400 moves first link430 in a forward direction, causing second link 440 to rotate aboutpivot point 442. In particular, pin 434 in second link 440 moves in acounter-clockwise motion relative to pivot point 442. Thecounter-clockwise motion of pin 434 draws curved needle 404 in acounter-clockwise retracting motion that opens throat 418. Conversely,rod 60 is movable backwards in a proximal direction that draws pin 432and link 430 rearward, which rotates pin 434 clockwise. Clockwiserotation of pin 434 connected between link 430 and link 440 causescurved needle 404 to move in a clockwise direction across throat 418 andinto cavity 422. In this manner, linkage 402 moves curved needle 404 outof needle exit port 420 and away from proximal end portion 414, acrossthroat 418, and into cavity 422 formed in distal end 412 of head 400.

Head 400 thus provides a reversed curved needle suture thrower that isconfigured to move curved needle 404 away from proximal end portion 414in an arc, across throat 418, and into engagement with capsule 152 (FIG.7) retained within cavity 422. Movement of rod 60 as described aboveretracts capsule from cavity 422 and pulls the capsule back into needleexit port 420.

A suturing system provides a suturing instrument having a needle housedin a proximal end portion of a head, where the needle is movablelongitudinally out of the proximal end portion of the head throughtissue to subsequently grasp a cap attached to suture. The needleretracts after engaging the cap and pulls the suture through the lesionformed by the needle in the tissue to efficiently throw and retrievesuture.

The suture 154 described above is suitably fabricated from a variety ofmaterials, including plastic materials (thermoplastic or thermosetmaterials). The capsule 152 described above in one embodiment is apolypropylene capsule that is thermoplastically formed (e.g., overmoldedor welded) with a polypropylene suture, although other forms ofconnecting the suture 154 to the capsule 152 are also acceptable.

Various embodiments provide a capsule or a leader that is attachable toany form of suture whether a thermoplastic suture, a resorbable suture,body-absorbable suture, a multi-filament suture, or a bioabsorbablesuture. Bioabsorbable sutures are generally fabricated from a materialhaving a melting point that is incompatible with overmolding to aplastic capsule. The cap or leader described herein is compatible withall forms of suture material, including bioabsorbable suture.

FIG. 18 is a side schematic view of one embodiment of a suture system500. The suture system 500 is configured to place a suture into tissueas described above and includes a tool 50 in the form of the suturingassembly 50 described above and a suture assembly 502.

The tool 50 includes the head 56 that provides the needle 62 disposedwithin the proximal portion 112. The needle 62 is movable through theneedle exit port 123 along the axis A and is configured to pitch orshunt from the axis A to a different axis aligned with the cavity 134for engagement with the suture assembly 502.

The suture assembly 502 includes a tubular leader 504 attached to an endof the suture 506. The tubular leader 504 is sized for placement insideof the cavity 134 and is configured to engage with the needle 62 toallow the needle 62 to extract the leader 504 from the cavity 134 anddelivered to the needle exit port 123. In one embodiment, the leader 504is mechanically, chemically, adhesively or otherwise attached to athermoplastic (e.g., polypropylene) suture. In one embodiment, theleader 504 is mechanically crimped or otherwise attached to abioabsorbable suture that is generally not suited for thermally bondingwith other plastic materials.

Suitable sutures 506 are available from Teleflex, Limerick, Pa. or CPMedical, Portland, Oreg. Other suitable sutures 506 are available fromEthicon™, a J&J Company located in Somerville, N.J., and includeresorbable and other sutures such as Monocryl™ (polyglycaprone 25)sutures, coated Vicryl™ (polyglactin 910) sutures, Ethicon Plus™Sutures, or polydioxanone sutures as examples. Examples of suitablebody-absorbable sutures are the Caprosyn™ Polysorb™, and Biosyn™absorbable sutures available from Covidien, Mansfield, Mass.

FIG. 19 is a perspective view of the tubular leader 504. In oneembodiment, the tubular leader 504 includes a body 510 and a clasp 512integrally formed with the body 510. In one embodiment, the body 510 isfabricated from plastic and the clasp 512 includes a portion that isovermolded by the plastic body 510 and a portion, such as the fingers514 that extend from the body 510. One suitable tubular leader 504includes a polypropylene body 510 that is overmolded over a portion of astainless steel clasp 512.

In one embodiment, the body 510 includes in annular wall 520 having anexterior surface 522 and an interior surface 524 that combine to providethe annular wall 520 with a bore 526. The bore 526 is sized to receiveand engage with the needle 62 (FIG. 18) that frictionally engages andthe tubular leader 504 and a portion of the length of suture 506 throughtissue in the manner described above. In one embodiment, the exteriorsurface 522 is formed to include a trough 528 that extends alongitudinally along the tubular leader 504.

FIG. 20 is a cross-sectional view of the tubular leader 504. The clasp512 includes a first portion 530 that is molded integrally within thebody 510 and a second portion 514 that extends out of the exteriorsurface 522 of the annular wall 520. The first portion 530 is thusencased by the body 510 and the fingers 514 extend freely from the body510 and are thus available for crimping onto the suture 506 (FIG. 18).The second portion 514, in this embodiment the fingers 514, are adaptedto secure the suture 506 against the exterior surface 522 of the tubularleader 504, and specifically within the trough 528. In this manner, thetubular leader 504 is configured to accommodate all forms of suturesincluding sutures fabricated from material that is incompatible withthermo-forming to the plastic material of the body 510. In oneembodiment, the body 510 of the tubular leader 504 is fabricated frompolypropylene that is overmolded over a stainless steel clasp 512 in amanner that allows the fingers 514 to secure a non-thermoplasticresorbable suture 506 to the leader 504.

In one embodiment, the exterior surface 522 of the annular wall 520includes a distal section 540 and a proximal section 542 that includes abulge 544. In one embodiment, the distal section 540 is formed to have asubstantially constant first diameter 550 that extends along the distalsection 540, and the bulge 544 is provided with a bulge diameter 554that is larger than the first diameter 550. The bulge diameter 554 ofthe bulge 544 is sized to frictionally retain the tubular leader 504 inthe cavity 134 (FIG. 18). In one embodiment, a portion of the proximalsection 542 is tapered to converge from the exterior surface 522 down toa proximal end 560 that has a proximal end diameter 562 that is smallerthan both the bulge diameter 554 and the first diameter 550. In oneembodiment, a diameter of the proximal section 542 is substantiallyequal to the first diameter 550.

In one embodiment, the interior surface 524 includes a flange 570 or aridge 570 that is provided to engage with a shoulder/recess provided onthe needle 62 (FIG. 18) as the needle 62 enters the bore 526.

FIGS. 21A and 21B are distal end views of embodiments of the tubularleader 504 attached to a length of suture 506. The first portion 530 ofthe clasp 512 is molded integrally within the body 510 and the fingers514, which form the second portion of the clasp 512, project out of theannular wall 520 and are crimped against the suture 506.

In the embodiment illustrated in FIG. 21A, the suture 506 is, forexample, a braided suture having a diameter that substantially fills thetrough 528 and the fingers 514 are crimped onto the suture 506 andproject slightly above the bulge 544. In the embodiment illustrated inFIG. 21B, the suture 506 is of a finer gauge than that illustrated inFIG. 21A and is retained in the trough 528. The fingers 514 are crimpedonto the suture 506 such that the fingers 514 do not extend beyond thebulge 544 (e.g., the fingers 514 and the suture 506 are contained withinthe area of the bulge 544). The embodiment illustrated in FIG. 21B thusprovides a frontal area of the leader 504 that is unaffected by thecrimping of the fingers 514 against the suture 506.

FIG. 22 is a cross-sectional view and FIG. 23 is a distal end view ofone embodiment of a tubular leader 604 suitable for use with the sutureassembly 502 illustrated in FIG. 18. In one embodiment, the tubularleader 604 includes a body 610 and a clasp 612 integrally formed withthe body 610 such that only a portion 614 of the clasp 612 extendsoutward from the body 610.

In one embodiment, the body 610 includes in annular wall 620 having anexterior surface 622 and an interior surface 624 that combine to providethe annular wall 620 with a bore 626 that is sized to receive and engagewith the needle 62 (FIG. 18).

In one embodiment, the clasp 612 includes a first portion 630 that ismolded integrally within the body 610 and the second portion 614 thatextends out of the interior surface 624 of the annular wall 620. Thesecond portion 614 of the clasp 612 is adapted to be crimped to securethe suture 506 against the interior surface 624 of the tubular leader504. In this manner, the tubular leader 604 is configured to accommodateall forms of sutures including sutures fabricated from material that isincompatible with thermo-forming to the plastic material of the body610. In one embodiment, the body 610 of the tubular leader 604 isfabricated from polypropylene that is overmolded over a stainless steelclasp 612 in a manner that allows the second portion 614 to secure anon-thermoplastic resorbable suture 506 to the leader 604.

In one embodiment, the exterior surface 622 of the annular wall 620includes a distal section 640, a proximal section 642 and a bulge 644,where the distal section 640 is formed to have a substantially constantfirst diameter 650 that extends along the distal section 640 and thebulge 644 is provided with a bulge diameter 654 that is larger than thefirst diameter 650. The bulge diameter 654 of the bulge 644 is sized tofrictionally retain the tubular leader 604 in the cavity 134 (FIG. 18).In one embodiment, the proximal section 642 is tapered to converge fromthe exterior surface 622 down to a proximal end 660 that has a proximalend diameter 662 that is smaller than both the bulge diameter 654 andthe first diameter 650.

In one embodiment, the interior surface 624 includes a flange 670 or aridge 670 that is provided to engage with a shoulder/recess provided onthe needle 62 (FIG. 18) as the needle 62 enters the bore 626.

In one embodiment described in reference to FIG. 18, the needle 62 is areciprocating needle movable proximally (e.g., forward) through theneedle exit 123 port formed in the proximal portion 112 of the head 56to the cavity 134 formed in the distal end 64 of the head 56 anddistally (e.g., rearward) from the cavity 134 formed in the distal end64 of the head 56 to the needle exit port 123 formed in the proximalportion 112 of the head 56. In one embodiment, the system 500 includesmeans for extracting the tubular leader 504/604 from the cavity 134 anddelivering it to the needle exit port 123. In one embodiment, the system500 includes means for disengaging, in the needle exit port 123, thetubular leader 504/604 from the needle 62.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

What is claimed is:
 1. A suture system configured to place suture intissue, the suture system comprising: a tool comprising a head having aproximal portion housing a needle and a distal end spaced apart from theproximal portion by a throat, the needle is movable through a needleexit port formed in the proximal portion of the head to a cavity formedin the distal end of the head; and a suture assembly comprising a lengthof suture connected to a tubular leader, the tubular leader including:an annular wall extending between an interior surface and an exteriorsurface, a clasp having a first portion disposed between the interiorsurface and the exterior surface of the annular wall and a secondportion extending out of the annular wall and adapted to secure thesuture against the annular wall; wherein the tubular leader is sized tobe placed in the cavity formed in the distal end of the head and theneedle is configured to engage with the interior surface of the tubularleader to extract the tubular leader from the cavity and deliver it tothe needle exit port.
 2. The suture system of claim 1, wherein theproximal portion of the head is aligned on a longitudinal axis of thetool and the needle exit port is formed on the longitudinal axis suchthat the needle moves through the needle exit port along thelongitudinal axis, and the cavity is disposed on a second axis that isnon-parallel relative to and offset radially from the longitudinal axis.3. The suture system of claim 2, wherein the tool is configured to pitchthe needle away from the longitudinal axis into alignment with thesecond axis to allow the needle to engage with a channel defined by theannular wall of the tubular leader.
 4. The suture system of claim 1,wherein the second portion of the clasp extends out of the exteriorsurface of the annular wall and is adapted to secure the suture againstthe exterior surface of the annular wall.
 5. The suture system of claim4, wherein the exterior surface includes a trough formed longitudinallyin the annular wall and the second portion of the clasp extends out ofthe exterior surface of the annular wall and is adapted to secure thesuture within the trough formed in the annular wall.
 6. The suturesystem of claim 1, wherein the second portion of the clasp extends outof the interior surface of the annular wall and is adapted to secure thesuture against the interior surface of the annular wall.
 7. The suturesystem of claim 1, wherein the clasp comprises a metal annular ring andthe first portion of the clasp is molded into plastic between theinterior surface and the exterior surface of the annular wall of thetubular leader and the second portion of the clasp comprises at leasttwo fingers that extend out of the annular wall.
 8. The suture system ofclaim 1, wherein the exterior surface of the annular wall comprises adistal section having a substantially constant first diameter along thedistal section and a proximal section having a bulge with a bulgediameter that is larger than the first diameter.
 9. The suture system ofclaim 8, wherein the bulge diameter of the bulge is sized tofrictionally retain the tubular leader in the cavity formed in thedistal end of the head.
 10. The suture system of claim 8, wherein theproximal section is tapered to converge from the bulge down to aproximal end that has a proximal end diameter that is smaller than boththe bulge diameter and the first diameter.
 11. The suture system ofclaim 1, wherein the tubular leader is attached to one of a resorbablesuture, a body-absorbable suture, a multi-filament suture, or abioabsorbable suture.
 12. A suture system configured to place suture intissue, the suture system comprising: a tool comprising a head having aproximal portion housing a needle and a distal end spaced apart from theproximal portion by a throat, the needle is movable through a needleexit port formed in the proximal portion of the head to a cavity formedin the distal end of the head; a suture assembly comprising a length ofsuture connected to a tubular leader, the tubular leader insertable intothe cavity formed in the distal end of the head and including: anannular wall extending between an interior surface and an exteriorsurface, a clasp having a first portion disposed between the interiorsurface and the exterior surface of the annular wall and a secondportion extending out of the annular wall and adapted to secure thesuture against the annular wall; and means for extracting the tubularleader from the cavity and delivering it to the needle exit port. 13.The suture system of claim 12, wherein the proximal head is aligned on alongitudinal axis of the tool and the needle exit port is formed on thelongitudinal axis; wherein the distal end of the head is offset radiallyoff of the longitudinal axis, and the needle is a reciprocating needlemovable proximally through the needle exit port formed in the proximalportion of the head to the cavity formed in the distal end of the head,and movable distally from the cavity formed in the distal end of thehead to the needle exit port formed in the proximal portion of the head.14. The suture system of claim 12, wherein the means for extracting thetubular leader from the cavity and delivering it to the needle exit portcomprises means for disengaging, in the needle exit port, the tubularleader from the needle.
 15. The suture system of claim 12, wherein thesecond portion of the clasp extends out of the exterior surface of theannular wall and is adapted to secure the suture against the exteriorsurface of the annular wall.
 16. The suture system of claim 12, whereinthe second portion of the clasp extends out of the interior surface ofthe annular wall and is adapted to secure the suture against theinterior surface of the annular wall.
 17. A suture assembly comprising:a tubular leader including an annular wall extending between an interiorsurface and an exterior surface, a clasp having a first portion encasedbetween the interior surface and the exterior surface of the annularwall and a second portion extending out of the annular wall; and alength of suture that is connected to a tubular leader by the secondportion of the clasp which presses the suture against the annular wall;wherein the tubular leader defines a bore that is sized to befrictionally engaged by a needle that pulls the tubular leader and aportion of the length of suture through tissue.
 18. The suture assemblyof claim 17, wherein the second portion of the clasp extends out of theexterior surface of the annular wall and is adapted to secure the sutureagainst the exterior surface of the annular wall.
 19. The sutureassembly of claim 17, wherein the second portion of the clasp extendsout of the interior surface of the annular wall and is adapted to securethe suture against the interior surface of the annular wall.
 20. Thesuture assembly of claim 17, wherein the tubular leader is attached toone of a resorbable suture, a body-absorbable suture, a multi-filamentsuture, or a bioabsorbable suture.